BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACRA-CUT XPRESS 120

    K Number: K032970 · Decision Dec 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    76

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    Basic Information

    Device Name
    ACRA-CUT XPRESS 120
    K Number
    K032970
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4305
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acra Cut, Inc.
    Date Received
    September 23, 2003
    Decision Date
    December 8, 2003
    Product Code
    HBF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)

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    Other Clearances by Acra Cut, Inc.

    K Number Device Name
    K944311 ACRA-CUT
    K911819 ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
    K911812 ACRA-CUT WIRE PASS DRILL
    K910225 BONE PAD REMOVER
    K910226 DURAL DISSECTORS
    K892866 AUTOMATIC CRANIAL DRILL (PERFORATOR)
    K833266 ACRA-CUT